{"abstract":"The Food and Drug Administration (FDA or we) is announcing the effective date for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, that appeared in the Federal Register of September 17, 2015.","action":"Final rule; announcement of effective date.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/10/31/2022-23534.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"117","title":21},{"chapter":null,"citation_url":null,"part":"507","title":21}],"citation":"87 FR 65527","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The effective date for the amendments to 21 CFR 117.405(a)(2), 117.435(d), and 117.475(c)(2), which published in the Federal Register of September 17, 2015 (80 FR 55908), is October 31, 2022. The effective date for the amendments to 21 CFR 507.105(a)(2), 507.135(d), and 507.175(c)(2), which published in the Federal Register of September 17, 2015 (80 FR 56170), is October 31, 2022.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0922"],"dockets":[{"supporting_documents":[{"title":"Reference 6 Standards for the Growing Harvesting and Holding of Produce RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2060"},{"title":"Reference 5 Part 117 FSMA Final Rulemaking for CGMP and HAPC for Human Food RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2059"},{"title":"Reference 4 Society of Plastics Letter May 3 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2058"},{"title":"Reference 3 Califonia Cotton Ginners Association Letter May 20 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0920-2057"},{"title":"Reference 99-Final Rule-World Trade Organization 1994-The WTO Agreement on the Application of Sanitary and Phytosanitary Measures re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2044"},{"title":"Reference 97-Final Rule-FDA 2013-Information for Foreign Governments_Frequently Asked Questions on Systems Recognition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2042"},{"title":"Reference 93-Final Rule-FDA 2012-Letter to Sunland Inc concerning Suspension of Food Facility Registration_Notice of Opportunity for Hearing re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2038"},{"title":"Reference 89-Final Rule-FDA 2008-Guidance for industry_Guide to minimize microbial hazards of fresh-cut fruits and vegetables re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2034"},{"title":"Reference 88-Final Rule-FDA 1995-Memorandum_Configuration of HACCP Plans re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2033"},{"title":"Reference 80-Final Rule-US Department of Health and Human Services 2015-Employers and Health Information in the Workplace HIPAA Privacy Rule re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food","document_id":"FDA-2011-N-0920-2029"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-10-31","updated_at":"2023-02-27T20:04:52.733-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0920-2068","allow_late_comments":null,"id":"FDA-2011-N-0920-2068","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":105,"id":"FDA-2011-N-0920","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food"},{"supporting_documents":[{"title":"Reference 4 Society of Plastics Letter May 3 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0922-0562"},{"title":"Reference 2. FRIA - ERG final - Animal Feed Safety System April 2011 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0542"},{"title":"Reference 60 FDA, Final Regulatory Impact Analyisis, 2015 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0536"},{"title":"Reference 59 Information for Foreign Governments-FAQ Systems Recognition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0535"},{"title":"Reference 58 GFSI Guidance Document Ver 63 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0534"},{"title":"Reference 50 FSIS Compliance Guideline HACCP Systems Validation re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0529"},{"title":"Reference 38 Recall  Primal Pet Foods Raw Frozen Cat Food Low Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0519"},{"title":"Reference 37 Recall Natura Pet Vitamin Insufficiency re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0518"},{"title":"Reference 36 Recall Cargill Excessive Levels of Sodium  Meatbird Feed re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0517"},{"title":"Reference 31 Recall P&G Cat Food Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0512"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-10-31","updated_at":"2023-02-27T20:04:52.334-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-N-0922-0567","allow_late_comments":null,"id":"FDA-2011-N-0922-0567","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":154,"id":"FDA-2011-N-0922","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food For Animals"}],"document_number":"2022-23534","effective_on":"2015-09-17","end_page":65527,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/10/31/2022-23534.xml","html_url":"https://www.federalregister.gov/documents/2022/10/31/2022-23534/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-23534?publication_date=2022-10-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-10-31/2022-23534/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1465,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-31/pdf/2022-23534.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-23534.pdf?1666961116","publication_date":"2022-10-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/10/31/2022-23534.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 4 Society of Plastics Letter May 3 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules","document_id":"FDA-2011-N-0922-0562"},{"title":"Reference 2. FRIA - ERG final - Animal Feed Safety System April 2011 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0542"},{"title":"Reference 60 FDA, Final Regulatory Impact Analyisis, 2015 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0536"},{"title":"Reference 59 Information for Foreign Governments-FAQ Systems Recognition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0535"},{"title":"Reference 58 GFSI Guidance Document Ver 63 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0534"},{"title":"Reference 50 FSIS Compliance Guideline HACCP Systems Validation re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0529"},{"title":"Reference 38 Recall  Primal Pet Foods Raw Frozen Cat Food Low Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0519"},{"title":"Reference 37 Recall Natura Pet Vitamin Insufficiency re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0518"},{"title":"Reference 36 Recall Cargill Excessive Levels of Sodium  Meatbird Feed re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0517"},{"title":"Reference 31 Recall P&G Cat Food Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals","document_id":"FDA-2011-N-0922-0512"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG10/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-food-","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals"},"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0922","supporting_documents_count":154,"docket_id":"FDA-2011-N-0922","document_id":"FDA-2011-N-0922-0567","regulation_id_number":"0910-AG10","title":"Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food For Animals","checked_regulationsdotgov_at":"2023-02-28T01:04:51Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65527,"subtype":null,"title":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and Onsite Audits; Announcement of Effective Date","toc_doc":"Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and Onsite Audits","toc_subject":"Effective Date:\n","topics":[],"type":"Rule","volume":87}